Health TrialsbyHealthPanel

Non-Invasive Quantification of Liver Health in NASH (N-QUAN)

ConditionNASH - Nonalcoholic Steatohepatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPerspectum

About this trial

To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \& F≥2 from those without.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and Female subjects aged between 18 and 75 years old

Ability to understand and sign a written informed consent forms

Patients scheduled to undergo a standard of care diagnostic liver biopsy as follows

Percutaneous biopsy with a 16 gauged needle passed into the right lobe

Disqualifiers

Prior histopathological diagnosis of NASH

Inability to undergo a liver biopsy

Prior or planned liver transplantation

Patient scheduled to undergo a laparoscopic or wedge liver biopsy or biopsy taken from the left lobe

Trial design

Design model

Single group

Treatments tested in this trial

  • Liver Multi Scan

    Diagnostic test

    MRI to create cT1, T2\* and PDFF images of patients liver.

Treatment groups

225 Participants
are divided into 1 treatment group
Group A: Study-gateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic performance of cT1

To evaluate, in patients with suspected Nash referred for Liver biopsy, the diagnostic performance of cT1 at discriminating those patients with NAS≥4 \& F≥2 from those patients without. In order to evaluate the diagnostic performance area under the receiver operative curve (AUROC) will be analysised.

Time frame
12 months

Secondary outcomes

1

Diagnostics performance of PDFF

To evaluate, inpatients with suspected NASH referred for liver biopsy, the diagnostic performance of PDFF at discriminating those with NAS≥4 from those without, and those with Brunt Steatosis≥2 from those without. The diagnostic performance will be determined using area under the receiver operative curve (AUROC) analysis.

Time frame
12 months
2

Correlation between cT1 and hisopathological features

To assess the correlation between cT1 and histopathological features of NASH and PDFF and histopathological features of NASH. The correlations will be explored using Spearman's Rho

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Perspectum

Lead sponsor

Source ClinicalTrials.gov
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